Sulfamethoxazole

精彩内容日前，康恩贝发布2023年业绩报告，全年实现营收67.33亿元，同比增长12.2%；归母净利润5.92亿元，同比增长65.19%。截至报告期末，公司拥有具有“三独”特色的产品接近100个，在研项目累计达200项，其中创新药及改良型新药项目占比6%。在中药领域，康恩贝手握46个独家品种（含独家剂型），改良型新药上市可期；在化学药方面，22个品种过评/视同过评，14个品种以新注册分类报产在审，1类新药步入I期临床。净利润大涨65%！近百个“三独”品种亮眼康恩贝成立于1969，经过五十多年的发展，现已成长为一家集药物研发、生产、销售于一体的大规模中药企业，并成功构建了以现代中药和植物药为核心，以特色化学药（原料药及制剂）、特色健康消费品为重要支撑的产品结构，涵盖消化代谢、呼吸、心脑血管、生殖泌尿、抗感染、肌肉骨骼等治疗领域。4月20日，康恩贝发布2023年业绩报告，公司全年实现营业收入67.33亿元，同比增长12.2%；归母净利润5.92亿元，同比增长65.19%。各业务板块营收较上年同期均有不同幅度的增长。全品类中药为康恩贝核心业务，2023年营收36.25亿元（+16.6%），其中中成药营收27.17亿元（+13.45%），中药材与中药饮片营收8.51亿元（+26.79%），中药保健品及中药提取物营收0.57亿元（+32.94%）；特色化学药营收23.91亿元（+2.98%），其中化学药制剂营收17.67亿元（+2.92%），原料药和兽药制剂营收6.24亿元（+3.18%）；特色健康消费品营收5.8亿元（+21.28%）；其他业务营收1.37亿元（49.29%）。近年来，康恩贝主动调整优化业务和产品结构，持续发力中药大健康核心主业，并推进大品牌大品种工程。2023年公司有17个品种销售收入超过1亿元，同比2022年增加2个。其中，全品类中药板块的核心产品肠炎宁系列产品销售收入同比增长28%，麝香通心滴丸、黄莪胶囊等保持增长；特色化学药板块的核心产品乙酰半胱氨酸泡腾片销售收入同比增长16%，氢溴酸加兰他敏片销售收入同比增长55%。目前康恩贝共计有60余个产品（按产品通用名计算）被列入2018版全国基药目录，160余个品种被列入2023版全国医保目录，拥有“三独”（独家品种、独家剂型、独家规格）特色的产品近100个。米内网数据显示，目前国内仅康恩贝（不含参股公司，下同）拥有生产批文的品种有54个，包括46个中成药、8个化学药。国内仅康恩贝拥有生产批文的品种（不含非制剂产品）来源：米内网中国上市药品（MID）数据库康恩贝积极推进科技创新驱动工程，逐年加大研发力度与强度，2023年公司研发投入3.12亿元，同比增长约19%。截至报告期末，康恩贝开展各类在研项目累计达200项，其中创新药及改良型新药项目占比6%，化学仿制药项目占比42%，中药二次开发项目占比29%，循证医学项目占比16%，其他项目占比7%。近年来康恩贝研发投入情况（单位：亿元）来源：公司公告，米内网整理手握15亿独家中成药，改良型新药上市可期持续聚焦以中药大健康为核心主业的产业发展战略，成为康恩贝近几年发展的主旋律。在中成药业务板块，目前康恩贝手握肠炎宁片、麝香通心滴丸等多个独家畅销品种，涵盖消化系统、心脑血管系统、呼吸系统、泌尿系统等多个治疗领域。肠炎宁片是康恩贝的拳头产品，为国家医保乙类、OTC甲类（双跨）品种，具有清热利湿、行气等功效，适用于大肠湿热所致的泄泻、痢疾等。近年来，公司紧抓市场机会加大品牌宣传，与医药电商、连锁药店等开展品牌共建、场景式营销等，肠炎宁系列产品保持快速增长。米内网数据显示，近年来中国零售药店终端（城市实体药店+网上药店）肠炎宁片的销售额均以两位数的增速上涨，2023年超过15亿元，同比增长32%。在肠道中成药产品排名中，肠炎宁片多年来稳居榜首，且市场份额逐年提升。近年来中国零售药店终端肠炎宁片销售情况（单位：万元）来源：米内网格局数据库中药二级保护品种麝香通心滴丸已被纳入国家医保乙类目录，具有芳香益气通脉、活血化瘀止痛等功效，适用于冠心病稳定型劳累性心绞痛（气虚血瘀证），症见胸痛胸闷、心悸气短、神倦乏力等。近年来麝香通心滴丸在中国三大终端六大市场的销售额逐年上涨，2022年超过3亿元，2023年上半年以20%的增速继续增长。在现代中药研发上，近年来康恩贝已取得黄蜀葵花总黄酮提取物及黄蜀葵花总黄酮口腔贴片的生产批文，在此之前，国内口腔溃疡市场尚无中药双层贴片产品获批上市。2023年12月，康恩贝公告称，黄蜀葵花总黄酮口腔贴片通过谈判纳入全国医保乙类目录，医保支付标准为1.75元/片。2018年至今康恩贝申报的部分中药新药来源：米内网中国申报进度（MED）数据库此外，中药2.1类改良型新药清喉咽含片已提交NDA，该产品由已上市非处方药清喉咽合剂更改剂型而来，具有养阴、清咽、解毒的功效，适用于阴虚肺热所致急性咽炎，症见咽喉肿痛、咳嗽、声音嘶哑、咽干灼热、耳闷及耳痛等。米内网数据显示，2022年中国三大终端六大市场咽喉中成药销售额接近70亿元。1.2类新药洋常春藤叶口服液获批临床，用于治疗急性气管炎-支气管炎引起的咳嗽、痰多，目前国内尚无将洋常春藤叶作为原料的相关药品制剂获批上市。米内网数据显示，2022年中国三大终端六大市场止咳祛痰平喘中成药销售额超过240亿元。14个新品冲刺上市，1类新药进攻400亿市场在化学药领域，目前康恩贝有22个仿制药过评/视同过评，集中在消化系统及代谢药、全身用抗感染药物、肌肉-骨骼系统等治疗领域，其中泮托拉唑钠肠溶片、复方磺胺甲噁唑片为首家过评。康恩贝过评情况注：带*为国采中标品种来源：米内网一致性评价进度数据库在已开展的国家集采中，康恩贝共有8个品种顺利中选，包括乙酰半胱氨酸颗粒、利伐沙班片等“光脚”品种（指集采前公司在该品种中销售占比较低或为0）。此外，康恩贝还有14个品种以新注册分类报产且在审（不含联合申报），获批生产后将视同通过一致性评价。其中，培哚普利氨氯地平片(Ⅲ)暂无国产企业获批，腺苷钴胺胶囊仅2家国产企业拥有生产批文。康恩贝新分类报产且在审的品种来源：米内网中国申报进度（MED）数据库在化药新药研发方面，1类新药EVT-401片正在开展I期临床，适应症为类风湿关节炎。米内网数据显示，2022年中国三大终端六大市场肌肉-骨骼系统药物（化药+生物药）销售规模超过400亿元。2022年至今康恩贝申报的部分化药新药来源：米内网中国申报进度（MED）数据库EVT-401是一款新型、口服、强力和选择性好的P2X7受体拮抗剂。目前全球暂无同靶点药物获批，在研产品最快进入II期临床，包括礼来的LY-3857210、强生的JNJ-55308942、辉瑞的CE-224535、阿斯利康的MT-002等，而在国内市场，EVT-401片是首个进入临床的P2X7受体拮抗剂。此外，康恩贝还有1款改良型新药吸入用吡非尼酮溶液获批临床，用于治疗特发性肺间质纤维化。吡非尼酮是一种具有广谱抗纤维化作用的吡啶酮类化合物，目前国内已获批上市的吡非尼酮制剂包括吡非尼酮片及吡非尼酮胶囊，2022年中国三大终端六大市场吡非尼酮销售额合计超过5.5亿元，2023年上半年突破4亿元。资料来源：米内网数据库、公司公告等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至4月30日，如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

Nearly half of women will get a urinary tract infection in their lifetime. For the first time in more than 20 years the FDA has approved an antibiotic to treat the condition. For the first time in more than 20 years, the FDA has approved a treatment for uncomplicated urinary tract infections (uUTI). And the nod has come for an oral antibiotic that has been available in Europe for more than 40 years. It’s an odd set of circumstances and a dose of foresight by Utility Therapeutics that bring Pivya (pivmecillinam) to the market in the United States in the therapy’s golden years. The London-based company was formed specifically to develop and commercialize pivmecillinam in the U.S. where antimicrobial resistance is growing to standard of care antibiotics. The decreased “utility” of first-line antibiotics and the void the company is attempting to fill in the U.S. were the inspiration of the name of the company. And the void is significant as more than 30 million uUTIs are diagnosed every year in the U.S., with nearly half of all women contracting the infection at some point in their life. Outside of hospital setting, UTIs account for more antibiotic use than any other disorder. In 2018, Utility inked a licensing agreement with LEO Pharma, acquiring the U.S. rights to pivmecillinam and its subcutaneous formulation mecillinam, which the company has submitted for approval as a first-line therapy for complicated urinary tract infections (cUTI) in the hospital setting. The difference between cUTIs and uUTIs is that the former has reached the kidneys while the latter is limited to the bladder. “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective and Pivya will provide an additional treatment option for uncomplicated UTIs,” Peter Kim, M.D., the director of the Division of Anti-Infectives at the FDA’s Center for Drug Evaluation and Research, said in a release. The year that Utility acquired the rights to pivmecillinam and mecillinam, the FDA signed off on each as a Qualified Infectious Disease Product (QIDP). The status is extended to antibacterial and antifungal drug candidates intended to treat serious or life-threatening infections. When a QIDP treatment is approved, it gains an additional five years of market exclusivity. On the same day in January, when Utility revealed that the FDA had accepted the company’s new drug applications for pivmecillinam and mecillinam, it also announced it had received private funding from the AMR Action Fund. The global initiative—which was established by several prominent drugmakers including Amgen, Bayer, Eli Lilly, GSK, Novo Nordisk and Roche—invests in the development of new antimicrobial therapeutics. In addition to being a prodrug, which means that it is not pharmacologically active until it is digested and absorbed into the system, Pivya has a unique mechanism of action, targeting penicillin binding protein-2 in the cell wall of gram-negative bacteria. Pivya’s efficacy was assessed in separate trials versus placebo, an oral antibacterial and ibuprofen. The primary measure of efficacy in the studies was the composite response rate, which included clinical cure (resolution of the symptoms of the uUTI that were present in patients at trial entry and no new symptoms) and microbiological response (demonstration that the bacteria cultured from patients’ urine at trial entry was reduced). In the placebo trial, 62% of the participants who received Pivya achieved composite response compared to 10% of those on placebo. In the oral antibacterial trial, 72% of the subjects who received Pivya achieved composite response versus 76% of those on the comparator. In the third trial, 66% of the subjects who received Pivya achieved composite response compared to 22% of those on ibuprofen.  Commonly prescribed drugs for uUTIs in the U.S. are bactrim (sulphamethoxazole/trimethoprim), nitrofuranatoin and fluoroquinolones. But more than 1 in 5 who receive these are resistant, which can lead to progression of the disease, including life-threatening sepsis. Last month, Germany’s Allecra Therapeutics scored FDA approval for its antibiotic Exblifep, which is a combination of cephalosporin antibacterial cefepime and the beta-lactamase inhibitor enmetazobactam, to treat cUTI. The approval came days after the U.S. regulator rejected another combo therapy in the same indication from Venatorx Pharmaceuticals and Melinta Therapeutics.